Postural Orthostatic Tachycardia Syndrome
Conditions
Brief summary
Postural orthostatic tachycardia (POTS) is characterized by abnormalities in the autonomic nervous system in the body. The autonomic nervous system controls and regulates body functions such as heart rate, breathing, digestion, and more. The investigator has shown that patients with POTS have higher cardiovascular and adrenergic activating autoantibodies (AAb), which likely changes the normal make-up of POTS. There are autoantibodies that have been suggested by a few reports of their presence in POTS, but their role different aspects of POTS is unknown. The study will look at the body's responses in patients with POTS. The crossover study design is to have half of the patients will start with sham followed by active stimulation and half will start by active followed by sham stimulation. It is anticipated that results will provide a potential therapeutic approach based on the understanding of POTS.
Interventions
DEVICEParasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
Sponsors
Dysautonomia International
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Female or male participants age 18-80 Group 1 (20 participants): * A physician-based diagnosis of POTS * Participants that have a postural pulse rise of \>35 for adolescents and \>30 for adults with a Blood Pressure (BP) that does not drop \>10/5 mmHg will be qualified. These participants may be on salt and fluid loading. Group 2 (10 participants): * Previously diagnosed with POTS * Patients is on Intravenous immunoglobulin (IVIG) infusion but who have an incomplete symptomatic response
Exclusion criteria
* Age \< 18 years * Sick sinus syndrome, 2nd or 3rd degree Atrioventricular (AV) block, bifascicular block or prolonged 1st degree AV block (PR\>300ms). * Currently pregnant women or women planning on becoming pregnant ≤ 6 months * History of hypotension due to autonomic dysfunction * Have a secondary causes of tachycardia (acute anemia or blood loss, drugs, significant cardiomyopathy, diabetes mellitus) * Patients with active implants (such as a cardiac pacemaker, or a cochlear implant).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average change in orthostatic heart rate | 2 and 4 months | We will measure the average change in heart rate between supine and standing using continuous ECG after two and four months of daily vagal nerve stimulation |
| Long term effects on M2 muscarinic autoantibody levels | 2 and 4 months | The average change in M2 muscarinic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation. |
| Long term effects on beta 1-adrenergic autoantibody levels | 2 and 4 months | The average change in beta 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation. |
| Long term effects on alpha 1-adrenergic autoantibody levels | 2 and 4 months | The average change in alpha 1-adrenergic autoantibody levels measured from blood specimens obtained after two and four months of daily vagal nerve stimulation. |
| Average change in heart rate variability | 2 and 4 months | We will measure the average change in heart rate variability based on 5 minute ECG after two and four months of daily vagal nerve stimulation |
Countries
United States
Outcome results
None listed